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The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60… μg/kg until toxicity supervenes.

Detailed Description:

To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on the (maximum tolerated dose) MTD, for subsequent clinical testing (Phase 2 recommended dose).

Eligibility

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible to participate in the study:

Confirmed diagnosis of HCL

Measurable disease

Patient's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted <2 years, or if the patient had unacceptable toxicity to purine analog.

ECOG performance status of 0-2.

Patients with other cancers who meet eligibility criteria and have less than 5 years of disease free survival will be considered on a case-by-case basis

Life expectancy of greater than 6 months, as assessed by the principal investigator

Must be able to understand and sign informed consent

Must be at least 18 years old

Female and male patients must agree to use an approved method of contraception during the study

Stage of Disease:

At least one of the following indications for treatment:

Neutropenia (ANC <1000 cells/μL),

Anemia (Hgb <10g/dL),

Thrombocytopenia (Plt <100,000/μL),

An absolute lymphocyte count of >20,000 cells/μL, or

Symptomatic splenomegaly

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for participation in the study:

History of allogeneic bone marrow transplant

Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)

Pregnant or breast-feeding females

Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.

The ANC < 1000/cmm, or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)

A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies

Baseline coagulopathy is greater than or equal to Grade 3 unless due to anticoagulant therapy

Pulmonary function:

Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed after bronchodilator therapy.

Recent prior therapy:

Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other systemic therapy, or any investigational therapy of the malignancy for 3 weeks prior to entry into the trial

Less than or equal to 1 month prior monoclonal antibody therapy (i.e. rituximab)

Patients who are receiving or have received radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port

Any history of prior pseudomonas-exotoxin(PE)immunotoxin administration

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586924